FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
10370-117
11-digit product format
103700117
Labeler code
10370
Product ID
10370-117_78c500a3-0492-4838-b8d2-c9a59aa43cdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA078148
Marketing category
ANDA
Marketing start
2011-04-14
Marketing end
2023-06-30
Substance
ZOLPIDEM TARTRATE
Active strength
6 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-117-10EA - Each10370-1172dd39804-181b-4f60-a589-087c0b2a1c5d12012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletPSNb7dd9153-61c4-463b-bab2-73c880a936431
854894zolpidem tartrate 6.25 MG Extended Release Oral TabletSCDb7dd9153-61c4-463b-bab2-73c880a936431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-117-1010370011710100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-117-10) 2011-04-140000-00-00NoNoCurrent